Vanderbilt medical center's supplier failed FDA review

Mar. 12, 2013

Written by

The Tennessean

Meeting today

The Tennessee Board of Pharmacy begins a two-day session at 9 a.m. today in the Iris Room at 227 French Landing. The agenda includes “Review and discuss compounding.”

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The only compounding pharmacy that shipped products to Vanderbilt University Medical Center turned out to be a lab that failed sterility safeguards, even though the hospital tried to check out its supplier.

Vanderbilt started retracing the supply line in November — the month after news broke that compounded drugs had caused a nationwide outbreak of fungal meningitis — but it didn’t finish the job. The origin of a product Vanderbilt used during heart transplants wound up being a lab in Chicago, not the Birmingham lab listed as the supplier. Vanderbilt did a site visit in Birmingham, but not Chicago.

“Even Vanderbilt has limited resources, and we chose not to visit that facility in Chicago,” Mark Sullivan, the hospital’s director of pharmacy inpatient services, told the Tennessee Board of Pharmacy in January.

Vanderbilt’s struggle to trace the origins of just one drug product illustrates the difficulty all hospitals and physician practices face in trying to independently ensure the safety of the medicines they use. They are trying to do that because of the ongoing fungal meningitis outbreak, which as of Monday has sickened 722 people nationwide, killing 50 of them. Patient safety advocacy organizations and members of Congress have blamed the U.S. Food and Drug Administration for failing to do its job by not acting on warnings about New England Compounding Center and not following through with punitive actions.

In a round of surprise inspections by the FDA this year, it cited the Chicago facility, Central Admixture Pharmacy Services (CAPS), in February for sterility lapses. The shortfalls ranged from an ineffective air monitoring system to technicians not wearing proper garb.

Vanderbilt stopped using the CAPS product this month. All of the hospital’s compounding is now done in-house, Sullivan said.

Traditionally, compounding was done by pharmacists to create specific medications needed by individual patients, but in recent years some compounders have turned the practice into more of a manufacturing process. FDA Commissioner Dr. Margaret Hamburg contends that current laws do not give her agency adequate oversight of compounding pharmacies so it can regulate them the way it regulates medicine manufacturers.

Vanderbilt is equipped to do compounding for multiple medical needs because it is part of a university research center. But other hospitals are also taking actions to better ensure the safety of medications. TriStar Health is doing more in-house compounding and has conducted some site visits of suppliers, said Karen Giorgio, director of marketing and public relations. The hospital system is asking its physicians to prescribe drug products made by manufacturers instead of compounding pharmacies when possible.

A spokesman for Saint Thomas Hospital said it did all its own compounding.

“The services of outside compounding pharmacies are not needed or utilized at Saint Thomas Hospital because the hospital has its own pharmacy and its own ability to compound medicine as required by ordering physicians,” said Rebecca Climer.

While Saint Thomas Outpatient Neurosurgical Center used the medicine linked to the outbreak, the hospital did not.

Vanderbilt ordered cardioplegia solution, a product used to paralyze and preserve cardiac muscle, from CAPS because making the product requires mixing chemicals that have a caustic reaction, Sullivan said.

Vanderbilt did not know the product originated in Chicago until Sullivan went to Birmingham.

“We were told they had centralized the expertise for making these very specialized solutions in their Chicago facility,” he said. “Then they ship those solutions down to their Birmingham facility for incorporating into these bags of fluid that they, in turn, send to us.”

He doubts the value of a scheduled inspection of a compounding pharmacy from a customer.

“You go and do an on-site inspection at a place, they know you are coming, so they put on a good show,” Sullivan said. “It’s a one-time look to see what’s going on and you don’t know what’s happening the next day. What’s the value in that?”

Hospitals can check FDA records, which are maintained online, to see if a compounding pharmacy has been cited for a safety or quality shortfall. The CAPS pharmacy in Birmingham had a clean record in recent years, but in 2006 it did recall cardioplegia solutions that had been shipped to 11 states, including Tennessee. An ingredient in the product had been mislabeled.